The present invention relates to headgear for use with an airway interface device or system. More particularly, it relates to headgear applied to an infant's head for supporting component(s) of an airway interface device or system, such as a patient interface portion of an infant nasal continuous positive airway pressure (nCPAP) system.
A variety of different therapies are delivered to a patient via the patient's nasal airways, such as delivery of breathable gases (e.g., oxygen). As another example, CPAP therapy has been employed for many years to treat patients experiencing respiratory difficulties and/or insufficiencies. In general terms, CPAP therapy entails the continuous transmission of positive pressure into the lungs of a spontaneously breathing patient throughout the respiratory cycle. More recently, CPAP therapy has been advanced as being useful in assisting patients with under-developed lungs (in particular, infants and especially premature infants or neonates) by preventing lung collapse during exhalation and assisting lung expansion during inhalation.
With these and other treatments, it is necessary to attach or secure one or more components to the patient's head. For example, air supply and/or exhaust tube(s) must be connected to the patient's airways and in turn, secured to the patient's head so as to not easily dislodge once connected. Typically, the supply tube(s) terminate in a conventional airway interface apparatus, such as a mask, nasal prongs, endotracheal tube, etc. With this approach, the interface apparatus is itself secured to the patient, such as by an elastic strap extending around a crown of the patient's head. With certain therapies, components in addition to the interface piece (e.g., mask or nasal prongs) must be secured relative to the patient. Certain CPAP formats, and in particular nasal CPAP (or “nCPAP”) systems, include not only the patient interface piece (otherwise adapted to interface with the patient's nasal airways) but also a CPAP generator adapted to create or generate a continuous positive airway pressure as well as various tubes extending to and from the CPAP generator. It is preferred that the CPAP generator be positioned in highly close proximity to the patient interface piece. As a result, the CPAP generator must be supported relative to the patient, along with the tube(s) extending to and from the generator. Other respiratory therapy systems have similar requirements.
In light of the above, a variety of different headgears have been developed for mounting and supporting the airway interface component(s) to a patient's head. As a general statement, headgear design efforts have been premised upon the perceived needs of adult patients. Adult patients oftentimes sit or stand upright when receiving the therapy in question, such that a majority of the airway interface component(s) is not located on (i.e., directly supported by) the patient's head. In fact, many adult airway interface headgears are concerned with maximizing mobility of the patient while wearing the device. To this end, it is common for adult headgear to be tightly strapped about the patient's head, and in particular about a crown of the patient's head. While patient comfort is desired, virtually no concern is given to possible trauma caused by pressure points created on the patient's head by the headgear once applied. An adult cranium is not readily damaged by the pressure associated with an even tightly strapped headgear, and the skin of an adult patient's head will typically not be damaged under normal conditions. Unfortunately, for other classes of patients, these factors cannot be dismissed.
Infants (especially premature infants or neonates) are particularly ill-suited for conventional airway interface headgear. Because an infant patient will not be upright, the airway interface device must be supported on or by the infant's head or face. Where the airway interface device entails more than a simple interface piece (e.g., CPAP generator and associated tubing in addition to a mask or nasal prongs), this presents a fairly significant design constraint, particularly in light of the relatively small surface area of an infant's head. In addition, infants are highly susceptible to pain and even long-term trauma when subjected to even a minor level of focused pressure. For example, headgear that generates a small, localized force can cause pressure sores and even necrosis on the infant's skin; under either condition, the infant's inherently low tolerance to pain will result in a strong resistance to wearing the headgear for even short periods. Further, an infant's skull is acutely underdeveloped and quite malleable. As such, headgear-related pressure points can cause positionable head molding.
In recognition of the above, some efforts have been made to design airway interface headgear adapted to better meet the needs of infant patients. The common approach for reducing pressure points on the infant's head is to employ a bonnet-like configuration that otherwise serves as the primary means of attachment. The bonnet fits over the infant patient's head and, in theory, evenly distributes pressure about the head. The bonnet typically forms one or more openings through which straps extending from the airway interface component(s) are threaded. While viable, the bonnet-type approach has several possible deficiencies. A size of the bonnet cannot be adjusted; as such, a hospital or other caregiver facility must maintain a large inventory of differently-sized headgears to accommodate different patients. Along these same lines, it may be difficult to consistently select the best-sized headgear for a particular patient. Further, due to the enclosed nature of the bonnet, application of the bonnet-type headgear to an infant patient often requires more than one caregiver. Similarly, assembly of the airway interface component(s) to the bonnet (e.g., threading the airway interface straps to the bonnet) can be a difficult and time-consuming task. Also, the bonnet, by design, covers nearly an entirety of the infant's head. For many infant patients, therapies in addition to the respiratory therapy in question are required, and are performed through the head (e.g., intravenous therapies delivered through a vein in the patient's head). Under these circumstances, the bonnet presents a distinct impediment and will required caregiver modification.
In light of the above, a substantial need exists for an improved airway interface headgear designed for use with infants. The headgear can be employed with a variety of airway-related therapy systems, for example nCPAP systems.